Over eighteen years of ISPE/ SMEPAC surrogate containment trials experience, professionally delivered and at a very keen price
D. Clough BSc. (Hons)
With experience of testing to <0.2 ng/m3 in air for the latest state-of-the-art isolation systems and additionally surface swab sampling. Envirotest has worked for most of the top Pharma and equipment companies both in the UK and abroad on OEB 1 to 6 containment equipment, including isolators, bulk transfer systems, laminar airflow booths and bespoke engineering solutions. Envirotest works in partnership with Maxxam Labs USA, utilising a range of surrogate powders, at specific milling specifications to produce detailed results to validate containment systems. The three surrogate powders that are most commonly used are; lactose, mannitol or naproxen sodium. The correct choice of which powder to use is critical to the success of each trial.
Our detailed reports always express results as “task based”, (8-hour TWA calculations can then be applied) they include the full independent laboratory report, (analysis is conducted blind by Maxxam Labs) with all sampling data included and no upfront background subtractions. Photographs and traceable calibration certification are given in each detailed report. Conclusions, including a pass or fail statement for the specification, along with any recommendations for improvement to operating procedures are all included as standard. Containment trials have been conducted across the world including United States, Ireland, France, Germany, Finland, Belgium, Italy, Netherlands, Sweden, Spain, Switzerland, Ukraine and South Korea.